A Study of Tocilizumab in Combination With DMARD Therapy in Patients With Active Rheumatoid Arthritis.

Sponsor
Hoffmann-La Roche
Study ID
NCT00773461
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

This 2 arm study will compare the safety and efficacy, with regard to reduction of signs and symptoms, of tocilizumab versus placebo, both in combination with DMARDs, in patients with active rheumatoid arthritis who currently have an inadequate response to DMARD therapy. Patients will be randomized 2:1 to receive tocilizumab 8mg/kg iv or placebo iv every 4 weeks, in conjunction with stable DMARD therapy. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Key Dates

Start date
Oct 31, 2008
Status verified
Jun 2017
Primary completion
Jul 22, 2010
Completion
Jul 22, 2010

Study Design

Enrollment
209 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 1
  • Placebo Comparator: 2

Primary Outcome Measure

Percentage of Participants With an American College of Rheumatology (ACR)20 Response at Week 24 [ Time Frame: Week 24 ]

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